The Effect of Therapeutic Play on Anxiety and Fear Levels in Children With Diabetes
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age9-12
SponsorIstanbul University - Cerrahpasa
About this trial
The study will be conducted using a randomized controlled method. Children with type 1 diabetes who are admitted to the Pediatric Endocrinology Service will be divided into two groups by randomization method. Following randomization, children in the experimental group will play a therapeutic game before their subcutaneous insulin treatment. In the subcutaneous insulin treatment of the children in the control group, the routine practice of the clinic will be applied. Anxiety and fear levels of all children in the experimental and control groups will be evaluated before and after subcutaneous insulin treatment.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
The child must be between the ages of 9 and 12 (since the State Anxiety Inventory for Children Scale is for this age range)
Diagnosed with type 1 diabetes
Absence of mental retardation
Receiving subcutaneous insulin treatment for the first time
Disqualifiers
Visual, hearing or speech impairment
Illiteracy of the child
Having a clinical condition that prevents playing games (excessive fatigue, weakness, etc.)
Trial design
Design model
Parallel
Treatments tested in this trial
Therapeutic Play
Other interventionChildren will be asked to fill in the "Child Patient Identification Form", "State Anxiety Scale in Children" and "Child Fear Scale" 30 minutes before insulin treatment. Before the insulin treatment, the children in the experimental group will have their blood glucose measured and insulin administered on a doll using the therapeutic play method. The child will be told that the doll is hospitalized with a diagnosis of Type 1 diabetes and will be expected to assume the role of a nurse to administer insulin to the doll. Then, the steps of blood glucose measurement and insulin treatment (subcutaneous) will be explained to the child and the child will be asked to administer insulin to the baby. Within 10 minutes after subcutaneous insulin treatment, the child will be asked to fill out the "State Anxiety Scale in Children" and "Child Fear Scale".
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: Therapeutic Play GroupExperimental treatment 1 intervention
Group B: Control GroupNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
State-Trait Anxiety Inventory for Children
Anxiety states of children that may occur due to subcutaneous insulin treatment will be evaluated. The lowest score that can be obtained from the State Anxiety Scale is 20 and the highest score is 60.
Time frame
30 minutes before insulin treatment, within 10 minutes after subcutaneous insulin treatment2
Child Fear Scale
Fear states of children that may occur due to subcutaneous insulin treatment will be evaluated. In this method, the child is shown a picture with five facial expressions rated between 0 and 4. 0 indicates no fear and anxiety, while 4 indicates the highest fear and anxiety.
Time frame
30 minutes before insulin treatment, within 10 minutes after subcutaneous insulin treatmentLocations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Istanbul University - Cerrahpasa
Lead sponsor
Fenerbahce University
Sponsor institution
Source ClinicalTrials.gov
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